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510(k) Data Aggregation

    K Number
    K201781
    Device Name
    Uni-FuZe-P Bone Putty
    Manufacturer
    Zavation Medical Products, LLC
    Date Cleared
    2020-12-28

    (181 days)

    Product Code
    MQV
    Regulation Number
    888.3045
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K173933,K051386
    Why did this record match?
    Reference Devices :

    K173933

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Uni-FuZe-P Bone Putty is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Uni-FuZe-P Bone Putty is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e.,extremities and pelvis). These defects may be surgically created osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

    Device Description

    Uni-FuZe-P Bone Putty is a resorbable bone void filler made from a matrix of bovine collagen (ASTM F2212), beta tricalcium phosphate (Beta-TCP per ASTM F1088), Bioglass 45S5 (ASTM F1538), and polyethylene glycol (PEG, 1450/600 blend). The implant is provided as sterile and is for single use.

    AI/ML Overview

    The provided document is a 510(k) premarket notification for a medical device called Uni-FuZe-P Bone Putty. It does not describe an AI/ML medical device and therefore does not contain information related to AI/ML acceptance criteria or studies proving performance in that context. The information requested in the prompt (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) is specific to the evaluation of AI/ML algorithms, which is not applicable to this traditional medical device submission.

    The document focuses on demonstrating substantial equivalence to a predicate device through:

    • Device Description: Composition (bovine collagen, beta tricalcium phosphate, Bioglass 45S5, polyethylene glycol), physical form (putty), and intended use as a resorbable bone void filler.
    • Indications for Use: For bony voids or gaps not intrinsic to bony structure stability, to be packed into skeletal system defects (extremities and pelvis).
    • Comparison of Technological Characteristics: Summarizes similarities in regulatory classification, materials, physical form, resorbability, porosity, and sterility with predicate and reference devices.
    • Performance Data:
      • Biocompatibility: Demonstrated acceptable biological safety profiles through Material-Mediated Pyrogenicity, Irritation, Sensitization, and Implantation tests (ISO 10993-1:2018, ISO 10993-6).
      • Bone Healing/Biological Response: Evaluated using an established rabbit functional femoral critical defect model at 1 day, 6, and 12 weeks. Measurements included radiographic images, micro-CT, and histological analyses. The study confirmed biocompatibility and a normal osteoconductive healing response, demonstrating substantial equivalence to the predicate device.
      • Bioactivity of Bioglass: Confirmed per ISO/FDIS 23317, with HA verified by SEM and XRD.
      • Collagen Stability: Verified using SDS-Page.
      • Packaging: Seal strength and integrity validated via peel strength (ASTM F88/F88M) and bubble emission (ASTM F2096).
      • Shipping & Handling: Validated per ASTM D7386.
      • Sterilization: Validated to an SAL of 10^-6 using VDmax of ANSI/AAMI/JSO 11137-2 (25 kGy minimum dose). LAL testing showed
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